Neck PainCCFNCT04193423
The Effects of Exercise Therapy for Flexor and Extensor Cervical Muscles on Non-specific Neck Pain.
A study of Neck Pain and Chronic Pain, run by University of Jaén at 1 site in Spain.
Trial summary
Objective: To compare the effects craniocervical and cervicothoracic extension training versus deep cervical flexor training, both combined with conventional treatment, on disability, perceived pain, Health-related quality of life (HRQoL), endurance, active range of motion (AROM) of the cervical spine, joint position… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain, Chronic Pain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSpain
- Study dates
- 2 Dec 2019to 6 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- non-specific neck pain (NSNP) for at least 3 months prior intervention commencement,
- age between 18 and 65 years,
- sedentary lifestyle,
- score > 5/50 on the Neck Disability Index (NDI) or score > 2 on the Numeric Rating Scale (NPRS) whose symptoms are not increased performing the exercises proposed in the study,
- limitation in the Active Range of cervical Motion (AROM) in flexion, extension, lateral inclination and/or rotation.
Who cannot join
- previous neck surgery,
- neck pain associated with whiplash injuries,
- subjects who ave received physical therapy 3 months prior intervention commencement,
- dizziness in the quadruped position, supine position, sitting or performing neck movements,
- pain in other parts od the body that prevents the performance of the exercises proposed in the study,
- neck pain accompanied by vertigo caused by vertebrobasilar insufficiency or pain accompanied by non-cervicogenic headaches,
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- neck pain with cervical radiculopathy and/or externalized cervical disc herniation,
- red flags: fracture, tumor or cervical infection or diagnosis of osteoporosis, metabolic diseases or rheumatoid arthritis,
- myopathy, ankylosing spondylitis or fibromyalgia,
- central nervous system involvement,
- pregnant women,
- severe psychiatric oe psychological disorders,
- subjects with pending legal action,
- not understand, write and speak spanish fluently.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Deep Cervical Flexors or Cervical Extensors Strengthening Program in Patients With Chronic Neck Pain, Does it Matter Which One to Choose?: A Randomized Clinical Trial
Objective:
To compare the effects craniocervical and cervicothoracic extension training versus deep cervical flexor training, both combined with conventional treatment, on disability, perceived pain, Health-related quality of life (HRQoL), endurance, active range of motion (AROM) of the cervical spine, joint position sense (JPS) and intake of drugs in subjects with non-specific chronic neck pain, referenced by the control group.
Read more
Methods:
The research will be done from December 2019 to August 2020 at the Recoletas Burgos Hospital.
Fifty-four volunteers with non-specific chronic neck pain, recruited at the hospital, will be randomly assigned, using sealed envelopes, to 1 of the three groups.
The first two experimental groups will be named Group A and Group B and each of them will go to the Rehabilitation Service for 4 weeks to perform the exercises under the supervision of the physiotherapist. This process will occur along with the conventional treatment (infrared heat, massage and transcutaneous electrical nerve stimulation). These groups will differ between them in the muscles they will mainly train through training. The group A will perform a neck extensor muscles training and group B a deep cervical flexor muscles training. After these 4 weeks, these exercises will be performed by them on a daily routine which will be prescribed for 6 months at home.
On the control group (group C), no intervention will be performed due to the fact that they will be still on the waiting list.
Disability, pain, HRQoL and drug intake will be measured in pre-treatment, at 4 weeks (post-treatment) and at 6 months follow-up; endurance, AROM and JPS will be measured in pre-treatment and at 4 weeks (post-treatment); while demographic variables (height, weight and age) will only be measured at the baseline.
- Conditions
- Neck Pain, Chronic Pain
- Being tested
- Neck extensors training versus deep cervical flexors training, compared to a control group.
- Keywords
- neck pain, exercise, training, endurance, intervention
- Medical subject headings
- Neck Pain, Chronic Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neck extensors training versus deep cervical flexors training, compared to a control group.Other
During the first month, the participants of the experimental groups will come at Rehabilitation Service to do the exercises individually and supervised by the physiotherapist and to received the conventional treatment (10 minutes of infrared heat, 10 minutes of massage and 15 minutes of TENS). The last six months, they will perform daily home exercises.
- A-group: the degrees respect to the floor in wich each participant can hold the craniocervical extension and the cervicothoracic extension during 5 seconds will bo measured with the BDI.
- B-group: Using an air-filled pressure sensor placed behind the neck, the physiotherapist will identify the target level that the patient can hold steadily a craniocervical flexion (CCF) for 5 seconds in a controlled manner. They will train following the protocol described by Jull et al.
Of each of this exercises, they will perform 10 isometric contractions, at the corresponding degrees or target level, of 10 seconds with a rest of 3-5 seconds.
| Study group | Role | What they receive |
|---|---|---|
| A-Group: craniocervical and cervicothoracic extension training | Experimental | Not described Receives: Other: Neck extensors training versus deep cervical flexors training, compared to a control group. |
| B-Group: craniocervical flexion training | Experimental | Not described Receives: Other: Neck extensors training versus deep cervical flexors training, compared to a control group. |
| C-Group: control group | Active comparator | No intervention will be performed due to the fact that they will be still on the waiting list. Receives: Other: Neck extensors training versus deep cervical flexors training, compared to a control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain related disability
using the Neck Disability Index (NDI) Questionnaire
Measured: Baseline, 1 month (primary timepoint) and 6 months after intervention.
Secondary outcomes (6)
Change in Neck pain
Using a Numeric Rating Scale (NPRS) from 0 to 10
Measured: Baseline, 1 month (primary timepoint) and 6 months after intervention.
Change in Health-related quality of life (HRQoL)
using the SF-36 quality of life questionnaire.
Measured: Baseline, 1 month (primary timepoint) and 6 months after intervention.
Change in Neck muscles endurance
Using the modified Neck Extensor Endurance test (NEE test) proposed by Lee el al. (2005) or the Neck Flexor Muscle Endurance Test (NFME test) with a chronometer and a BDI
Measured: Baseline and 1 month (primary timepoint).
Change in Active Range of cervical Motion (AROM)
Using a digital inclinometer
Measured: Baseline and 1 month (primary timepoint).
Change in Joint Position Sense (JPS)
Using a target and a rule
Measured: Baseline and 1 month (primary timepoint).
Change in Frequency of use of drugs
Using a shelf-completed drug registration document
Measured: Baseline, 1 month (primary timepoint) and 6 months after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start2 Dec 2019
- Primary completion2 Nov 2021
- Study completion6 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It is a randomized controlled clinical trial with parallel groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jaén
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Achalandabaso, University of Jaén
- Investigators
- Achalandabaso, Study director, University of Jaén
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04193423
- Sponsor's protocol ID
- CEIM/HU/2019/28
- Other IDs
- U1111-1241-3966
- Acronym
- CCF
- Status last verified
- May 2022
- First submitted
- 5 Dec 2019
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Cervical Flexors or Cervical Extensors Strengthening Program in Patients With Chronic Neck Pain, Does it Matter Which One to Choose?: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04193423
- Acronym / sponsor ID
- CCF / CEIM/HU/2019/28
- Conditions
- Neck Pain, Chronic Pain
- Keywords
- neck pain, exercise, training, endurance, intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- 2 Nov 2021 (actual)
- Study completion
- 6 May 2022 (actual)
- First posted
- 10 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective:
To compare the effects craniocervical and cervicothoracic extension training versus deep cervical flexor training, both combined with conventional treatment, on disability, perceived pain, Health-related quality of life (HRQoL), endurance, active range of motion (AROM) of the cervical spine, joint position sense (JPS) and intake of drugs in subjects with non-specific chronic neck pain, referenced by the control group.
Methods:
The research will be done from December 2019 to August 2020 at the Recoletas Burgos Hospital.
Fifty-four volunteers with non-specific chronic neck pain, recruited at the hospital, will be randomly assigned, using sealed envelopes, to 1 of the three groups.
The first two experimental groups will be named Group A and Group B and each of them will go to the Rehabilitation Service for 4 weeks to perform the exercises under the supervision of the physiotherapist. This process will occur along with the conventional treatment (infrared heat, massage and transcutaneous electrical nerve stimulation). These groups will differ between them in the muscles they will mainly train through training. The group A will perform a neck extensor muscles training and group B a deep cervical flexor muscles training. After these 4 weeks, these exercises will be performed by them on a daily routine which will be prescribed for 6 months at home.
On the control group (group C), no intervention will be performed due to the fact that they will be still on the waiting list.
Disability, pain, HRQoL and drug intake will be measured in pre-treatment, at 4 weeks (post-treatment) and at 6 months follow-up; endurance, AROM and JPS will be measured in pre-treatment and at 4 weeks (post-treatment); while demographic variables (height, weight and age) will only be measured at the baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- It is a randomized controlled clinical trial with parallel groups.
| Arm | Type | Receives |
|---|---|---|
| A-Group: craniocervical and cervicothoracic extension training | Experimental | Other: Neck extensors training versus deep cervical flexors training, compared to a control group. |
| B-Group: craniocervical flexion training | Experimental | Other: Neck extensors training versus deep cervical flexors training, compared to a control group. |
| C-Group: control group | Active comparator | Other: Neck extensors training versus deep cervical flexors training, compared to a control group.No intervention will be performed due to the fact that they will be still on the waiting list. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- non-specific neck pain (NSNP) for at least 3 months prior intervention commencement,
- age between 18 and 65 years,
- sedentary lifestyle,
- score > 5/50 on the Neck Disability Index (NDI) or score > 2 on the Numeric Rating Scale (NPRS) whose symptoms are not increased performing the exercises proposed in the study,
- limitation in the Active Range of cervical Motion (AROM) in flexion, extension, lateral inclination and/or rotation.
Key exclusion criteria (14 listed)
- previous neck surgery,
- neck pain associated with whiplash injuries,
- subjects who ave received physical therapy 3 months prior intervention commencement,
- dizziness in the quadruped position, supine position, sitting or performing neck movements,
- pain in other parts od the body that prevents the performance of the exercises proposed in the study,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neck extensors training versus deep cervical flexors training, compared to a control group.During the first month, the participants of the experimental groups will come at Rehabilitation Service to do the exercises individually and supervised by the physiotherapist and to received the conventional treatment (10 minutes of infrared heat, 10 minutes of massage and 15 minutes of TENS). The last six months, they will perform daily home exercises. * A-group: the degrees respect to the floor in wich each participant can hold the craniocervical extension and the cervicothoracic extension during 5 seconds will bo measured with the BDI. * B-group: Using an air-filled pressure sensor placed behind the neck, the physiotherapist will identify the target level that the patient can hold steadily a craniocervical flexion (CCF) for 5 seconds in a controlled manner. They will train following the protocol described by Jull et al. Of each of this exercises, they will perform 10 isometric contractions, at the corresponding degrees or target level, of 10 seconds with a rest of 3-5 seconds. | Other | A-Group: craniocervical and cervicothoracic extension training, B-Group: craniocervical flexion training, C-Group: control group |
Primary outcome
Change in Pain related disability
Time frame: Baseline, 1 month (primary timepoint) and 6 months after intervention.
using the Neck Disability Index (NDI) Questionnaire
6 secondary outcomes
Change in Neck pain
Time frame: Baseline, 1 month (primary timepoint) and 6 months after intervention.
Change in Health-related quality of life (HRQoL)
Time frame: Baseline, 1 month (primary timepoint) and 6 months after intervention.
Change in Neck muscles endurance
Time frame: Baseline and 1 month (primary timepoint).
Change in Active Range of cervical Motion (AROM)
Time frame: Baseline and 1 month (primary timepoint).
Change in Joint Position Sense (JPS)
Time frame: Baseline and 1 month (primary timepoint).
Change in Frequency of use of drugs
Time frame: Baseline, 1 month (primary timepoint) and 6 months after intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Achalandabaso study director
University of Jaén
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Neck Pain and Chronic Pain, run by University of Jaén at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain related disability (time frame: Baseline, 1 month (primary timepoint) and 6 months after intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2022.